the influence of igy max on inflammatory markers and the gut microbiome

Conditions: Healthy

Summary: the purpose of this study is to determine the optimal dose of igy as assessed by changes in the inflammatory marker, c-reactive protein and investigate the effect of igy on the gut microbiome as assessed by 16s rna sequencing of fecal samples.


Eligibility criteria:
inclusion criteria: * male or female adults aged 18 - 60 (inclusive) * self-reported complaints of minor gastrointestinal symptoms (i.e. occasional gas, bloating, etc.) * non-smoker, or ex-smoker ≥6 months * body mass index 25.0- 34.9kg/m2 (inclusive) * female subjects of childbearing potential \[i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)\] must have negative urine pregnancy test and must be using an effective birth control method * willing to avoid alcohol consumption for 24 h prior to every clinic visit * willing to maintain their regimens of medications and supplements known to alter gi function (including, but not limited to, iron supplements, calcium, and anti-depressants) * willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed * willing and able to provide informed written consent exclusion criteria: * pregnancy or lactation, or subject unwilling to take appropriate contraceptives for the duration of the study * use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs \>1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within 3 months prior to visit 1 * unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1 * use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 3 months prior to visit * use of over the counter or prescription laxatives or stool softeners within 1 month prior to baseline (v2) * use of antibiotics (other than topical) within 2 months prior to baseline (v2) * use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (fos, gos), psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 4 weeks of baseline (v2) and consumption of foods fortified with prebiotics (e.g. inulin) or probiotics within 2 weeks of baseline (v2) * history of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin) * individuals with achlorhydria * presence of major diseases such as diabetes, gastrointestinal disease, cardiovascular disease, pancreatic, renal, or liver disease * chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel disease * abdominal or gastrointestinal surgery within the previous 12 months or planned abdominal or gastrointestinal surgery in the next 4 months * recent gastrointestinal food-borne illness (within 1 month prior to visit 1) * history of neurological disease (e.g. parkinson's disease, stroke, traumatic brain injury, etc.) * history of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past 5 years * uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmhg and/or diastolic blood pressure ≥90 mmhg * abnormal laboratory test results of clinical significance, including, but not limited to alt or ast ≥1.5x the upper limit of normal at screening (visit 1) * presence or history (past 6 months) of alcohol or drug abuse; alcohol use of \>2 standard alcoholic drinks per day * extreme dietary habits (e.g. vegan or very low carbohydrate diets) * subject has a known allergy or intolerance to the test products or placebo * subject is unwilling or unable to abide by the requirements of the protocol * any condition that would interfere with the subject's ability to comply with study instructions, might confound the interpretation of the study, or put the subject at risk * subject has taken an investigational health product or has participated in a research study within 30 days prior to first study visit

Keywords: gastrointestinal microbiome inflammation